NCT07577817RecruitingEarly phase 1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.
A Phase 1, 3-Part, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of CTX001 in Healthy Adult Participants.
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
This study is testing CTX001 for certain conditions where the body does not have enough available iron or has difficulty storing or moving iron properly. The purpose of this study is to investigate any side effects that may happen with CTX001, how CTX001 is absorbed by and processed in the body, and how CTX001 affects iron levels in the blood when administered with or without iron and/or food.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 5 May 2026
- Start date
- Jun 2026
- Primary completion date
- Oct 2026
- Lead sponsor
- Cajal Therapeutics Inc.
- Diseases
- Chronic kidney disease
- NCT number
- NCT07577817
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 72
- From Jun 2026 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has any concurrent disease or condition or physical, psychological, mental, and/or social reason that, in the opinion of the Investigator, would make the participant unsuitable for participation in the clinical study
- Has received a blood transfusion within 1 year
- Requires prescription medication or regular use of non-prescription medication
Other illness
- Is a regular user of cannabis or has a history of illicit drug abuse within 1 year
- Has a history of alcohol abuse or binge drinking within 6 months
- Has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator
Other
- Has dietary requirements that may be difficult to accommodate
- Is a regular user of tobacco or nicotine-containing products
- Unwilling or unable to comply with the lifestyle guidelines described in the protocol
- Has donated whole blood within 6 months or plasma within 30 days
- Is an employee of the Sponsor, the CRO, or of any organization or site(s) associated with this study, or any immediate family member who is in a dependent relationship with a study site employee who is involved in the conduct of the study
Who the study is looking for
- Capable of giving informed consent
- Agrees to use effective contraception
- Body Mass Index (BMI) between 18.0 and 32.0 kg/m2
- Healthy by medical evaluation and medical history
- Hematological parameters, serum iron, transferrin and ferritin are within normal range and transferrin saturation is within normal range and greater than or equal to 20%
- Can swallow tablets and has suitable venous access for blood sampling
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nucleus Network Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.